Breast and Prostate Cancer Data Quality and Patterns of Care Study, 33146-33154 [05-11254]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 108 (Tuesday, June 7, 2005)]
[Notices]
[Pages 33146-33154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Breast and Prostate Cancer Data Quality and Patterns of Care 
Study

    Announcement Type: New.
    Funding Opportunity Number: CDC-RFA-DP05-071.
    Catalog of Federal Domestic Assistance Number: 93.395.
    Key Dates:
Release Date: May 11, 2005.
Letters of Intent Receipt Date: May 27, 2005.
Application Receipt Date: June 28, 2005.
Earliest Anticipated Start Date: August 31, 2005.
Expiration Date: June 29, 2005.
    Due Dates for E.O. 12372:
    Not applicable.

I. Funding Opportunity Description

Executive Summary

     This RFA will support up to six registries to conduct 
enhanced surveillance and operations research utilizing population-
based data from the National Program of Cancer Registries (NPCR). The 
research will focus on improving the completeness, timeliness, quality, 
and use of first course of treatment and stage data, and on describing 
patterns of care for female breast cancer and prostate cancer. A long 
term goal is to strengthen the capacity of NPCR funded state cancer 
registries to use their data to improve aspects of cancer care.
     It is estimated that approximately $2 million will be 
available each year to fund up to six registries. A total of 
approximately $6 million will be available for the entire three year 
project period.
     This funding opportunity will use the cooperative 
agreement funding mechanism (CDC U58).
     Eligible organizations include NPCR funded cancer 
registries, or their designated agent, meeting United States Cancer 
Statistics (USCS) publication criteria for the diagnosis year 2000 or 
2001. For-profit organizations, non-profit organizations, public and 
private institutions, units of State government, and domestic 
institutions that can provide evidence of an active collaboration with 
their respective NPCR funded cancer registry are also eligible to 
apply.
     Individuals with the skills, knowledge, and resources 
necessary to carry out the proposed research are invited to work with 
their institution to develop an application for support. Individuals 
from underrepresented racial and ethnic groups as well as individuals 
with disabilities are always encouraged to apply for CDC funding 
announcements.
     An applicant may submit only one application under this 
funding announcement.
     Applications must be prepared using the ``Application for 
a DHHS Public Health Service Grant'' (PHS 398, rev. 9/04). The PHS 398 
instructions and forms are available at https://grants.nih.gov/grants/
forms.htm.
     Telecommunications for the hearing impaired is available 
at: TTY 301-451-0088

Table of Contents

Part I Overview Information
Section I. Funding Opportunity Description
    1. Research Objectives
Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available
Section III. Eligibility Information
    1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
    2. Cost Sharing or Matching
    3. Other--Special Eligibility Criteria
Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
    1. Letter of Intent
    B. Sending an Application to the CDC
    C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements
Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates
Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
    1. Principal Investigator Rights and Responsibilities
    2. NCCDPHP Responsibilities
    3. Collaborative Responsibilities
    4. Arbitration Process
    3. Reporting
Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)
Section VIII. Other Information--Required Federal Citations

I. Funding Opportunity Description

    The purpose of this RFA is to support research focused on two 
priority cancers, female breast cancer and prostate cancer, which will 
build on and expand the work of two Patterns of Care (PoC) projects 
conducted collaboratively by CDC and selected state cancer registries. 
This program addresses the ``Healthy People 2010'' focus areas of 
Access to Quality Health Services and Cancer.
    Measurable outcomes of the program will be in alignment with the 
following performance goals for the National Center for Chronic Disease 
Prevention and Health Promotion (NCCDPHP): (1) To improve the quality 
of state-based cancer registries, (2) to increase early detection of 
breast and cervical cancer by building nationwide programs in breast 
and cervical prevention, especially among high-risk, underserved women, 
and (3) to expand community-based breast and cervical cancer screening 
and diagnostic services to low income, medically underserved women. For 
women diagnosed with cancer or pre-cancer, ensure access to treatment 
services.

1. Research Objectives

Nature of Research Opportunity
    The research priorities of the Centers for Disease Control and 
Prevention's (CDC) Cancer Surveillance Branch, within the Division of 
Cancer Prevention and Control, are to describe the burden of priority 
cancers and patterns of care among minority, rural, and other 
populations and to assess the quality of these data in NPCR funded 
cancer registries. This RFA builds on and extends the work of two 
patterns of care (PoC) projects conducted collaboratively by CDC and 
selected state cancer registries. It solicits applications in the form 
of cooperative agreements to utilize data from NPCR

[[Page 33147]]

funded cancer registries to perform enhanced surveillance and research 
regarding patterns of care in female breast and prostate cancers.
    Recently published statistics from United States Cancer Statistics: 
2001 Incidence and Mortality, a joint publication of CDC and the 
National Cancer Institute in collaboration with the North American 
Association of Central Cancer Registries, revealed that prostate cancer 
is the leading cancer diagnosed in men in the United States (U.S.) and 
breast cancer is the most common form of cancer diagnosed in U.S. 
women. Prostate and female breast cancers are the second leading cause 
of cancer death among men and women.
Background
    In 1992, Congress established the NPCR by enacting the Cancer 
Registries Amendment Act (Public Law 102-515). This law, generally, 
authorizes the Centers for Disease Control and Prevention to provide 
funds to states and territories to: improve existing cancer registries; 
plan and implement registries where they do not exist; develop model 
legislation and regulations to enhance the viability of registry 
operations; set data standards for data completeness, timeliness, and 
quality; provide training for registry personnel; and help establish a 
computerized reporting and data-processing system.
    The Institute of Medicine (IOM) reported in 1999 that some 
individuals with cancer were not receiving the care known to be the 
most effective for their cancer diagnoses. Subsequently in 2000, the 
IOM strongly recommended that information from existing data systems, 
specifically NPCR, be used to assess the quality of cancer care and 
variations in adherence to established standards of care in the United 
States. In addition, the 2000 IOM report also documented the need to 
assess the quality of data in NPCR funded registries for measuring 
variations in the delivery of cancer care.
    In 2001, CDC responded to the IOM report by funding the Breast, 
Prostate, and Colon Data Quality and Patterns of Care study (PoC Part 
1) involving eight NPCR funded cancer registries. This study was 
designed to assess the quality of data collected by population-based 
registries and to determine the proportion of patients diagnosed within 
a certain time period who received the established, stage-specific 
standard of care. The eight NPCR funded cancer registries also 
participated in Phase II of the international CONCORD study, which 
sought to measure and explain differences in cancer survival between 
Europe, Canada, and the United States. Additionally, CDC funded three 
NPCR cancer registries for a second PoC study, Ovarian Cancer Treatment 
Patterns and Outcomes (PoC Part 3), which was designed to describe the 
first course of treatment for ovarian cancer and to assess the effects 
of physician specialty on the quality of staging and treatment data.
Scientific Knowledge To Be Achieved Through This Funding Opportunity
    The research to be supported by this RFA will focus on improving 
the completeness, timeliness, quality, and use of recent first course 
of treatment and stage data and on describing patterns of care for two 
priority cancers, female breast cancer and prostate cancer. Additional 
research on the patterns of care for patients diagnosed with these two 
cancers, and continued assessment of the quality and completeness of 
relevant data collected by population-based cancer registries, has the 
potential to influence adherence to established standards of cancer 
care. A long term goal of conducting such studies is to further develop 
the capacity of NPCR funded registries to engage in advanced cancer 
surveillance activities that will contribute to improving aspects of 
cancer care.
Experimental Approach and Research Objectives
    Using a standardized protocol for data collection by the 
participating NPCR funded registries, enhanced surveillance and 
research will be conducted targeting female breast cancer and prostate 
cancer. The four broad research objectives of this RFA are to:
    (1) Determine the proportion of patients who received the 
recognized standard of care for stages I through III female breast 
cancer.
    (2) Describe the treatment patterns for all stages of prostate 
cancer.
    (3) Determine the tumor, patient, provider, and health system 
characteristics that are associated with different cancer treatments 
for female breast and prostate cancers.
    (4) Assess the completeness and quality of the stage and first 
course of treatment data that are collected by cancer registries for 
female breast and prostate cancers.
    These four research objectives will focus on the two most recent 
diagnosis years available, as determined by the Steering Committee and 
defined in the study protocol.
    See Section VIII, Other Information--Required Federal Citations, 
for policies related to this announcement.

II. Award Information

1. Mechanism(s) of Support

    This funding opportunity will use the CDC (U58) cooperative 
agreement award mechanism. The award recipient will be solely 
responsible for planning, directing, and executing the proposed 
project. In the cooperative agreement mechanism, the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NCCDPHP 
staff being substantially involved as a partner with the Principal 
Investigator, as described under the Section VI. 2. Administrative 
Requirements, ``Cooperative Agreement Terms and Conditions of Award''.
    This funding opportunity uses the just-in-time budget concepts. It 
requires summary budget information provided in the application 
package, including the budget justification and support, written in the 
form, format, and the level of detail as specified in the budget 
guidelines. You may access the latest version of the budget guidelines 
by accessing the following Web site: https://www.cdc.gov/od/pgo/funding/
budgetguide2004.htm.
    This RFA is a one-time solicitation. The total project period for 
an application submitted in response to this RFA may not exceed three 
years

2. Funds Available

    The NCCDPHP intends to commit approximately $2 million in FY 2005 
to fund up to six new competitive cooperative agreements in response to 
this RFA. An applicant may request a project period of up to three 
years and a maximum budget for total costs of $333,000 per year. 
Approximately $6 million will be available for the entire three years.
    The earliest anticipated start date is August 31, 2005, with three 
performance periods between September 2005 and September 2008.
    Although the financial plans of the NCCDPHP provide support for 
this program, awards pursuant to this funding opportunity are 
contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. Continuation of awards 
will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the Federal Government.

[[Page 33148]]

Section III. Eligibility Information

1. Eligible Applicants

1. A. Eligible Institutions
    You may submit an application if your organization has any of the 
following characteristics:
     Public nonprofit organizations
     Private nonprofit organizations
     For profit organizations
     Universities
     Colleges
     Research institutions
     Hospitals
     State and local governments or their Bona Fide Agents 
(this includes the District of Columbia, the Commonwealth of Puerto 
Rico, the Virgin Islands, the Commonwealth of the Northern Marianna 
Islands, American Samoa, Guam, the Federated States of Micronesia, the 
Republic of the Marshall Islands, and the Republic of Palau)
    A Bona Fide Agent is an agency/organization identified by the state 
as eligible to submit an application under the state eligibility in 
lieu of a state application. If you are applying as a bona fide agent 
of a state or local government, you must provide a letter from the 
state or local government as documentation of your status. Place this 
documentation behind the first page of your application form.
    Institution eligibility is limited to those with broad research 
capacity and access to the data sources and populations necessary to 
conduct the research activities of the RFA.
1. B. Eligible Individuals
    Any individual with the skills, knowledge, and resources necessary 
to carry out the proposed research is invited to work with their 
institution to develop an application for support. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for CDC programs.

2. Cost Sharing or Matching

    Cost sharing is not required.

3. Other-Special Eligibility Criteria

    The following criteria will be used to determine an applicant's 
eligibility:
    1.a. NPCR funded cancer registries, or their designated agent, 
meeting United States Cancer Statistics (USCS) publication criteria for 
either diagnosis year 2000 or 2001. Publication criteria are 
demonstrated through case ascertainment of >=90% with <=5% of cases 
being ascertained by death certificate only, <=5% of cases missing 
race, <=3% of cases missing sex and age, and >=97% of cases passing a 
set of single-field and inter-field computerized edits. Funding will be 
contingent on registry data meeting USCS publication criteria for 
diagnosis year 2002.
    1.b. NPCR funded cancer registries that have a minimum of 2,000 
female breast cancer cases (stages I through III) and 2,000 prostate 
cancer cases (all stages) over the two year period, as demonstrated in 
Appendix E of the 2000 and 2001 publications of USCS.
    2. Public or private institutions that can demonstrate an effective 
and well-defined working relationship between the institution and the 
NPCR funded cancer registry in that state. Evidence must be provided in 
the form of a Letter of Support from the NPCR funded registry 
describing the strong working relationship and assuring access to data 
for the period of the study.
    Investigators may submit only one application under this funding 
announcement. If your application is incomplete or non-responsive to 
the special eligibility requirements listed in this section, it will 
not be entered into the review process and you will be notified that 
your application did not meet the submission requirements. Applicants 
that request a funding amount greater than the award ceiling will be 
considered non-responsive.

    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in Section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

Section IV. Application and Submission Information

1. Address To Request Application Information

    The PHS 398 application instructions are available at PHS 398 
Application Form in an interactive format. Applicants must use the 
currently approved version of the PHS 398. If you do not have access to 
the Internet, or if you have difficulty accessing the forms on-line, 
you may contact the CDC Procurement and Grants Office Technical 
Information Management Section (PGO-TIM) staff at: 770/488-2700, e-
mail: PGOTIM@cdc.gov.

2. Content and Form of Application Submission

    Applications must be prepared using the most current PHS 398 
research grant application instructions and forms. Applications must 
have a D&B Data Universal Numbering System (DUNS) number as the 
universal identifier when applying for Federal grants or cooperative 
agreements. The D&B number can be obtained by calling 866/705-5711 or 
through the Web site at https://www.dnb.com/us/. The D&B number should 
be entered on line 11 of the face page of the PHS 398 form.
    The title and number of this funding opportunity must be typed on 
line 2 of the face page of the application form and the YES box must be 
checked.

3. Submission Dates and Times

    Applications must be received on or before the receipt date 
described below (Section IV.3.A).
3.A. Receipt, Review, and Anticipated Start Dates
    Letter of Intent Receipt Date: May 27, 2005.
    Application Receipt Date: June 38, 2005.
    Peer Review Date: Week of July 25, 2005.
    Earliest Anticipated Start Date: August 31, 2005.
    Explanation of Deadlines: All requested information must be 
received in the CDC Procurement and Grants Office by 4 p.m. eastern 
time on the deadline date.
    If you submit your LOI or application by the United States Postal 
Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission after closing due to: (1) carrier 
error, when the carrier accepted the package with a guarantee for 
delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the submission as having 
been received by the deadline.
    This announcement is the definitive guide on LOI and application 
content, submission address, and deadlines. It supersedes information 
provided in the application instructions. If your application does not 
meet the deadline above, it will not be eligible for review and will be 
discarded. You will be notified that you did not meet the submission 
requirements.
    CDC will not notify you upon receipt of your submission. If you 
have a question about the receipt of your LOI or application, first 
contact your courier. If you still have a question, contact the PGO-TIM 
staff at: 770/488-2700. Before calling, please wait two to three days 
after the submission deadline. This will allow time for submissions to 
be processed and logged.

[[Page 33149]]

3.A.1. Letter of Intent
    CDC requests that prospective applicants send a Letter of Intent 
(LOI). Although an LOI is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that 
it contains allows NCCDPHP staff to estimate the potential reviewer 
workload and plan the review.
    LOI format:
     Two page maximum, one side only.
     One-inch margins, 12 point font, single spaced.
    LOI contents:
     Number and title of this funding opportunity (RFA or PA)
     Descriptive title of proposed research.
     Name, address, e-mail, and telephone number of the 
Principal Investigator.
     Names of other key personnel.
     Participating Institutions.
    The LOI should be mailed, faxed, or e-mailed by May 27, 2005, to: 
Office of Extramural Research, NCCDPHP, Centers for Disease Control and 
Prevention, 4770 Buford Highway, NE., Mailstop K-92, Atlanta, GA 30341. 
Telephone: 770/488-8390. Fax: 770/488-8046. E-mail: OER@cdc.gov.
3.B. Sending an Application
    Applications must be prepared using the PHS 398 research grant 
application instructions and forms as described above. Submit a signed, 
typewritten original of the application, including the checklist, and 
two signed photocopies in one package to: Technical Information 
Management-CDC-RFA DP-05-071, CDC Procurement and Grants Office, 2920 
Brandywine Road, Atlanta, GA 30341.
    At the time of submission, three additional copies of the complete 
application, including the appendix material, must be sent to: Brenda 
Colley Gilbert, Ph.D., M.S.P.H., Centers for Disease Control and 
Prevention, Office of Extramural Research, NCCDPHP, 4770 Buford 
Highway, NE., Mailstop K-92, Atlanta, GA 30341.
    FedEX Address: Brenda Colley Gilbert, Ph.D., M.S.P.H., Office of 
Extramural Research, NCCDPHP, Koger Center/Williams Building, 2877 
Brandywine Road, Room 5516, Atlanta, GA 30341.
    For further assistance contact the CDC Procurement and Grants 
Office, Technical Information Management Section: telephone 770/488-
2700, e-mail pgotim@cdc.gov.
3.C. Application Processing
    Applications must be received on or before the application receipt 
date described above (Section IV.3.A.). If an application is received 
after that date, it will be returned to the applicant without review.
    Upon receipt, applications will be evaluated for completeness by 
the Procurement and Grants Office (PGO) and responsiveness by the 
NCCDPHP. Incomplete and non-responsive applications will not be 
reviewed.

4. Intergovernmental Review

    Executive Order 12372 does not apply to this program.

5. Funding Restrictions

    Restrictions, which must be taken into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is a provisional rate, the agreement should be less than 12 
months of age.

6. Other Submission Requirements

    The general instructions in the PHS 398 should be followed; 
however, applications must also include the following:
    1. A work plan describing activities to meet the project goals and 
objectives and demonstrating the capability to abstract the required 
number of cases.
    2. A personnel plan describing the team members' roles in carrying 
out the objectives of the project, including the planned percent of 
effort for team members.
    3. A timeline that adequately demonstrates appropriate distribution 
of project activities over the three year study period.
    4. Letters of support from collaborating partners that provide 
evidence of an active collaboration and commitment to work as full 
partners.
    This announcement requires summary budget information provided in 
the application package, including the budget justification and 
support, written in the form, format, and the level of detail as 
specified in the budget guidelines. You may access the latest version 
of the budget guidelines by accessing the following Web site: https://
www.cdc.gov/od/pgo/funding/budgetguide2004.htm.
    Projects that involve the collection of information from ten or 
more individuals and funded by cooperative agreement will be subject to 
review and approval by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act.

Section V. Application Review Information

1. Criteria

    Applicants are required to provide measures of effectiveness that 
will demonstrate the accomplishment of the various identified 
objectives of the cooperative agreement. Measures of effectiveness must 
relate to the performance goals stated in Section I. Funding 
Opportunity Description of this announcement. Measures must be 
objective and quantitative, and must measure the intended outcome. 
These measures of effectiveness must be submitted with the application 
and will be an element of evaluation.
    The goals of CDC-supported research are to advance the 
understanding of biological systems, improve the control and prevention 
of disease and injury, and enhance health. In the written comments, 
reviewers will be asked to evaluate the application in order to judge 
the likelihood that the proposed research will have a substantial 
impact on the pursuit of these goals.
    The following will be considered in making funding decisions:
     Scientific merit of the proposed project as determined by 
peer review.
     Availability of funds.
     Relevance of program priorities.
    Preference may be given to applications based on evidence of 
accessibility to populations with racial/ethnic and socio-economic 
diversity necessary to achieve socio-economic and racial/ethnic 
representation of the United States population.

2. Review and Selection Process

    Upon receipt, applications will be reviewed for completeness by PGO 
and responsiveness by the NCCDPHP. Incomplete and/or non-responsive 
applications will not be reviewed. Applicants will be notified that 
their application did not meet submission requirements.
    Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an external peer review 
group convened by the NCCDPHP in accordance with the review criteria 
stated below.
    As part of the initial merit review, all applications will:
     Undergo a selection process in which only those 
applications deemed to have the highest scientific merit, generally the 
top half of applications under review, will be discussed and assigned a 
priority score.

[[Page 33150]]

     Receive a written critique within 30 days after the 
review.
    Scored applications will receive a second level of review by the 
NCCDPHP Secondary Review Committee. The review process will follow the 
policy requirements as stated in the GPD 2.04 (https://198.102.218.46/
doc/gpd204.doc).
    The following review criteria will be addressed and considered in 
assigning the overall score, weighting them as appropriate for each 
application. Note that an application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score. For example, an investigator may propose 
to carry out important work that by its nature is not innovative but is 
essential to move a field forward.
    1. Significance. Does this study address an important problem? If 
the aims of the application are achieved, how will scientific knowledge 
or clinical practice be advanced? What will be the effect of these 
studies on the concepts, methods, technologies, treatments, services, 
or preventative interventions that drive this field?
    2. Approach. Are the conceptual or clinical framework, design, 
methods, and analyses adequately developed, well integrated, well 
reasoned, and appropriate to the aims of the project? Does the 
applicant acknowledge potential problem areas and consider alternative 
tactics?
    Does the work plan describe activities that meet the project goals 
and objectives and demonstrate the capability to abstract the required 
number of cases? Does the personnel plan describe the team members' 
roles in carrying out the objectives of the project? Are the PI's and 
other team members' percent effort adequate for the conduct of the 
study? Is a timeline provided that demonstrates appropriate 
distribution of project activities over the three-year study period? 
Does the applicant provide evidence of the capacity to engage in 
advanced cancer surveillance activities that will ultimately contribute 
to improving aspects of cancer care?
    3. Innovation. Is the project original and innovative? For example: 
Does the project challenge existing paradigms or clinical practice; 
address an innovative hypothesis or critical barrier to progress in the 
field? Does the project develop or employ novel concepts, approaches, 
methodologies, tools, or technologies for this area?
    Does the project have the potential to provide insights about 
patterns of care in diverse racial, ethnic, geographic, socio-economic, 
and other special populations?
    4. Investigators. Are the investigators appropriately trained and 
well suited to carry out this work? Is the work proposed appropriate to 
the experience level of the principal investigator and other 
researchers? Does the investigative team bring complementary and 
integrated expertise to the project (if applicable)?
    Does the project team have expertise in cancer surveillance 
research or provide evidence of recent preparation that would enhance 
its successful involvement in such a project?
    5. Environment. Does the scientific environment in which the work 
will be done contribute to the probability of success? Do the proposed 
studies benefit from unique features of the scientific environment, or 
subject populations, or employ useful collaborative arrangements? Is 
there evidence of institutional support?
2. A. Additional Review Criteria
    Collaboration. Does the applicant provide evidence of an active 
collaboration and commitment to work as full partners? Do current or 
past cancer surveillance projects involve successful collaborations 
between the researchers and the partnering public or private 
institutions?
    In addition to the above criteria, the following items will 
continue to be considered in the determination of scientific merit and 
the priority score:
    Protection of Human Subjects from Research Risk. Federal 
regulations (45 CFR part 46) require that applications and proposals 
involving human subjects be evaluated and that they reference the risk 
to the subjects, the adequacy of protection against these risks, the 
potential benefits of the research to the subjects and others, and the 
importance of the knowledge gained or to be gained (https://www.hhs.gov/
ohrp/humansubjects/guidance/45cfr46.htm). The involvement of human 
subjects and protections from research risk relating to their 
participation in the proposed research will be assessed (see the 
Research Plan, Section E on Human Subjects in the PHS Form 398).
    Inclusion of Women, Minorities and Children in Research. Does the 
application adequately address the CDC Policy requirements regarding 
the inclusion of women, ethnic, and racial groups in the proposed 
research? This includes: (1) The proposed plan for the inclusion of 
both sexes and racial and ethnic minority populations for appropriate 
representation; (2) the proposed justification when representation is 
limited or absent; (3) a statement as to whether the design of the 
study is adequate to measure differences when warranted; and (4) a 
statement as to whether the plans for recruitment and outreach for 
study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
2. B. Additional Review Considerations
    Budget: The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research. The priority 
score should not be affected by the evaluation of the budget.

3. Anticipated Announcement and Award Dates

    CDC expects to make awards on or about August 31, 2005.

Section VI. Award Administration Information

1. Award Notices

    After the peer review of the application is completed, the 
Principal Investigator will receive a written critique called a Summary 
Statement. Those applications under consideration for funding will 
receive a call or email from the Grants Management Specialist (GMS) of 
the Procurements and Grants Office (PGO) with additional information.
    A formal notification in the form of a Notice of Award (NoA) will 
be provided to the applicant organization. The NoA signed by the Grants 
Management Officer (GMO) is the authorizing document. This document 
will be mailed and/or emailed to the institutional fiscal officer 
identified in the application.
    Selection of the application for award is not an authorization to 
begin performance. Any cost incurred before receipt of the NoA is at 
the recipient's risk. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

    The Code of Federal Regulations 45 CFR part 74 and part 92 have 
details about policy requirements. For more information on the Code of 
Federal Regulations, see the National Archives and Records 
Administration at the following Internet address: https://
www.access.gpo.gov/nara/cfr/cfr-table-search.html. The following 
additional requirements can be found in Section VIII. Other Information 
of this document or on the CDC Web site at the following Internet 
address: https://www.cdc.gov/od/pgo/funding/ARs.htm. These will be 
incorporated into the award statement and will be provided to the 
Principal Investigator, as well as to the

[[Page 33151]]

appropriate institutional official, at the time of award.
2. A. Cooperative Agreement Terms and Conditions of Award
    The following special terms of award are in addition to, and not in 
lieu of, otherwise applicable OMB administrative guidelines, HHS grant 
administration regulations at 45 CFR Parts 74 and 92 (Part 92 is 
applicable when State and local Governments are eligible to apply), and 
other HHS, PHS, and CDC grant administration policies.
    The administrative and funding instrument used for this program 
will be the cooperative agreement (CDC U58), an ``assistance'' 
mechanism (rather than an ``acquisition'' mechanism), in which 
substantial NCCDPHP programmatic involvement with the awardees is 
anticipated during the performance of the activities. Under the 
cooperative agreement, the NCCDPHP's purpose is to support and 
stimulate the recipients' activities by involvement in, and otherwise 
working jointly with, the award recipients in a partnership role; it is 
not to assume direction, prime responsibility, or a dominant role in 
the activities. Consistent with this concept, the dominant role and 
prime responsibility resides with the awardees for the project as a 
whole, although specific tasks and activities may be shared among the 
awardees and the NCCDPHP as defined above.
2. A.1. Principal Investigator Rights and Responsibilities
    The Principal Investigator at each research site will have the 
primary responsibility to lead the efforts of the research team to:
    1. Participate effectively within the research collaborative group, 
composed of investigators from each of the research sites and CDC 
investigators, to develop the specific research questions to be 
addressed in the project (Section I Research Objectives, 1-4) and the 
resulting standard research protocol, including the study design, 
design of the instruments, development of study methods and procedures, 
collection, analysis and interpretation of data, and methods for 
dissemination of results.
    2. Assist in the development of a research protocol for the 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially, and on at least an annual basis, until 
the research project is completed.
    3. Collaborate with other study investigators and follow common 
protocols and manuals of operation developed by the Steering Committee.
    4. Obtain an annual, updated local institutional IRB approval.
    5. Assure and maintain the confidentiality of all study data.
    6. Participate actively in CDC site visits designed to support and 
enhance research progress and performance.
    7. Participate in the analyses of aggregated study data and state-
specific data.
    8. Develop and produce technical reports or manuscripts for peer-
reviewed publications.
    9. Serve as a member of the Steering Committee that will provide 
scientific oversight for the study.
    10. Participate in national, regional, and local communication of 
study development, implementation, and findings to public, 
professional, and governmental organizations and agencies, through 
written, oral, and electronic means.
    11. Communicate state-specific findings to the public, cancer 
registry, and medical and cancer control communities through 
presentations and publications.
    Awardees will retain custody of and have primary rights to the data 
and software developed under these awards, subject to Government rights 
of access consistent with current HHS, PHS, and CDC policies and 
applicable federal laws and regulations.
2. A.2. NCCDPHP Responsibilities
    A NCCDPHP Project Scientist and PoC multidisciplinary team will 
have substantial programmatic involvement that is above and beyond the 
normal stewardship role in awards, as described below:
    1. Participate in the development of the study by providing 
scientific consultation and technical assistance in the development of 
the research questions, study design and protocol, the development of 
sampling procedures, the design of the instruments, development of 
study methods and procedures, including collection, analysis, and 
interpretation of data, resolution of data quality issues, and 
dissemination of results.
    2. Facilitate communication among recipients for the development of 
a common protocol, quality control, interim data monitoring, data 
analysis, interpretation of findings, reporting, and coordination of 
activities, through written, oral, and electronic means.
    3. Support the recipients' activities by collaborating and 
providing ongoing scientific and public health consultation and 
assistance in the development of activities related to the cooperative 
agreement, including conducting site visits to recipient institutions.
    4. Facilitate movement of the initial research protocol through the 
CDC Institutional Review Board (IRB), including keeping the CDC IRB 
abreast of protocol amendments, and facilitating annual reviews.
    5. Participate in joint data analyses and interpretation and the 
presentation and publication of findings.
    6. Collaborate in producing technical reports and manuscripts for 
peer-reviewed publications, as appropriate.
    7. Facilitate distribution and dissemination of research findings.
    8. Assure and maintain the confidentiality of all study data.
    Additionally, an agency program official or the NCCDPHP program 
director will be responsible for the normal scientific and programmatic 
stewardship of the award and will be named in the award notice.
2. A.3. Collaborative Responsibilities
    The following are areas of joint responsibility between the award 
recipients and the NCCDPHP project team:
    1. Participation in the development of a Steering Committee that 
will provide scientific oversight for the study. The Steering 
Committee, the main governing board of the study, will be composed of 
the Principal Investigator from each research site and a NCCDPHP 
Project Scientist serving as consultant. The role of chairperson will 
be rotated among the Principal Investigators of the research sites. The 
Principal Investigators must have proven evidence of leadership ability 
and be able to make an adequate time commitment to the cooperative 
agreement.
    The Steering Committee, in collaboration with NCCDPHP project 
scientists, will meet initially to develop the protocol and throughout 
the year to discuss the progress of the study. It will have primary 
responsibility for developing a common research design, protocols and 
manuals of operations, facilitating the conduct and monitoring of 
studies, developing policies relating to access to patient data, and 
reporting study results. The Steering Committee must approve the 
protocol, changes to protocols, and manuals of operation. The Principal 
Investigator of each research site will be responsible for the 
execution of the protocol and will provide progress reports to the 
Steering Committee. The Steering Committee will establish guidelines 
for presentations at scientific meetings and for writing and publishing 
manuscripts on the findings of the study.
    2. Identify ways to collaborate with cancer care providers and 
others to use

[[Page 33152]]

research findings to improve care to patients.
    3. Establish agreements for sharing data.
    Each full member will have one vote. Grantee members of the 
Steering Committee will be required to accept and implement policies 
approved by the Steering Committee.

3. Reporting

    Grantees must provide CDC with an original, plus two hard copies of 
the following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC website) no less than 90 days 
before the end of the budget period. The progress report will serve as 
your non-competing continuation application and must contain the 
following elements:
    a. Current Budget Period Activities Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activity Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Annual Progress Report, due 90 days after the end of the budget 
period.
    3. Financial status report, no more than 90 days after the end of 
the budget period.
    4. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the ``Agency Contacts'' section of this announcement.

Section VII. Agency Contacts

    We encourage your inquiries concerning this funding opportunity and 
welcome the opportunity to answer questions from potential applicants. 
Inquiries may fall into three areas: Scientific/research, peer review, 
and financial or grants management issues:

1. General Questions

    Technical Information Management Section, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770/
488-2700. E-mail: PGOTIM@cdc.gov.

2. Scientific/Research Contacts

    Brenda Colley Gilbert, PhD, M.S.P.H., Centers for Disease Control 
and Prevention, Office of Extramural Research, NCCDPHP, 4770 Buford 
Highway, NE., Mailstop K-92, Atlanta, GA 30341. Telephone: 770/488-
8390. E-mail: BColleyGilbert@cdc.gov.

3. Peer Review Contacts

    Scientific Review Administrator, Centers for Disease Control and 
Prevention, Office of Extramural Research, NCCDPHP, 4770 Buford 
Highway, NE., Mailstop K-92, Atlanta, GA 30341. Telephone: 770/488-
8390. E-mail: OER@cdc.gov.

4. Financial or Grants Management Contacts

    Lucy Picciolo, Procurements and Grants Office, Centers for Disease 
Control and Prevention, Koger Office Park, Colgate Building, Mailstop 
E-14, Atlanta, GA 30341-5539. Telephone: 770/488-2683. E-mail: 
lip6@cdc.gov.

Section VIII. Other Information

Required Federal Citations

AR-1 Human Subjects Requirements
    If the proposed project involves research on human subjects, the 
applicant must comply with the Department of Health and Human Services 
(DHHS) Regulations (Title 45 Code of Federal Regulations Part 46) 
regarding the protection of human research subjects. All awardees of 
CDC grants and cooperative agreements and their performance sites 
engaged in human subjects research must file an assurance of compliance 
with the Regulations and have continuing reviews of the research 
protocol by appropriate institutional review boards.
    In order to obtain a Federalwide Assurance (FWA) of Protection for 
Human Subjects, the applicant must complete an on-line application at 
the Office for Human Research Protections (OHRP) Web site or write to 
the OHRP for an application. OHRP will verify that the Signatory 
Official and the Human Subjects Protections Administrator have 
completed the OHRP Assurance Training/Education Module before approving 
the FWA. Existing Multiple Project Assurances (MPAs), Cooperative 
Project Assurances (CPAs), and Single Project Assurances (SPAs) remain 
in full effect until they expire or until December 31, 2003, whichever 
comes first.
    To obtain a FWA contact the OHRP at: https://ohrp.osophs.dhhs.gov/
irbasur.htm. Or:
    If your organization is not Internet-active, please obtain an 
application by writing to: Office for Human Research Protections 
(OHRP), Department of Health and Human Services, 6100 Executive 
Boulevard, Suite 3B01, MSC 7501, Rockville, Maryland 20892-7507. (For 
express or hand delivered mail, use ZIP code 20852.)

    Note: In addition to other applicable committees, Indian Health 
Service (IHS) institutional review committees must also review the 
project if any component of IHS will be involved with or will 
support the research. If any American Indian community is involved, 
its tribal government must also approve the applicable portion of 
that project.

AR-2 Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
    It is the policy of the Centers for Disease Control and Prevention 
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) 
to ensure that individuals of both sexes and the various racial and 
ethnic groups will be included in CDC/ATSDR-supported research projects 
involving human subjects, whenever feasible and appropriate. Racial and 
ethnic groups are those defined in OMB Directive No. 15 and include 
American Indian or Alaska Native, Asian, Black or African American, 
Hispanic or Latino, Native Hawaiian or Other Pacific Islander. 
Applicants shall ensure that women, racial and ethnic minority 
populations are appropriately represented in applications for research 
involving human subjects. Where clear and compelling rationale exist 
that inclusion is inappropriate or not feasible, this situation must be 
explained as part of the application. This policy does not apply to 
research studies when the investigator cannot control the race, 
ethnicity, and/or sex of subjects. Further guidance to this policy is 
contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, 
and dated Friday, September 15, 1995.
AR-9 Paperwork Reduction Act Requirements
    Under the Paperwork Reduction Act, projects that involve the 
collection of information from ten or more individuals and funded by a 
grant or a cooperative agreement will be subject to review and approval 
by the Office of Management and Budget (OMB).
AR-10 Smoke-Free Workplace Requirements
    CDC strongly encourages all recipients to provide a smoke-free 
workplace and to promote abstinence from all tobacco products. Public 
Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain 
facilities that receive Federal funds in which education, library, day 
care, health care, or early childhood development services are provided 
to children.

[[Page 33153]]

AR-11 Healthy People 2010
    CDC is committed to achieving the health promotion and disease 
prevention objectives of ``Healthy People 2010,'' a national activity 
to reduce morbidity and mortality and improve the quality of life. For 
the conference copy of ``Healthy People 2010,'' visit the Internet 
site: https://www.health.gov/healthypeople.
AR-12 Lobbying Restrictions
    Applicants should be aware of restrictions on the use of HHS funds 
for lobbying of Federal or State legislative bodies. Under the 
provisions of 31 U.S.C. 1352, recipients (and their sub-tier 
contractors) are prohibited from using appropriated Federal funds 
(other than profits from a Federal contract) for lobbying Congress or 
any Federal agency in connection with the award of a particular 
contract, grant, cooperative agreement, or loan. This includes grants/
cooperative agreements that, in whole or in part, involve conferences 
for which Federal funds cannot be used directly or indirectly to 
encourage participants to lobby or to instruct participants on how to 
lobby.
    In addition, no part of CDC appropriated funds, shall be used, 
other than for normal and recognized executive-legislative 
relationships, for publicity or propaganda purposes, for the 
preparation, distribution, or use of any kit, pamphlet, booklet, 
publication, radio, television, or video presentation designed to 
support or defeat legislation pending before the Congress or any State 
or local legislature, except in presentation to the Congress or any 
State or local legislature itself. No part of the appropriated funds 
shall be used to pay the salary or expenses of any grant or contract 
recipient, or agent acting for such recipient, related to any activity 
designed to influence legislation or appropriations pending before the 
Congress or any State or local legislature.
    Any activity designed to influence action in regard to a particular 
piece of pending legislation would be considered ``lobbying.'' That is 
lobbying for or against pending legislation, as well as indirect or 
``grass roots'' lobbying efforts by award recipients that are directed 
at inducing members of the public to contact their elected 
representatives at the Federal or State levels to urge support of, or 
opposition to, pending legislative proposals is prohibited. As a matter 
of policy, CDC extends the prohibitions to lobbying with respect to 
local legislation and local legislative bodies.
    The provisions are not intended to prohibit all interaction with 
the legislative branch, or to prohibit educational efforts pertaining 
to public health. Clearly there are circumstances when it is advisable 
and permissible to provide information to the legislative branch in 
order to foster implementation of prevention strategies to promote 
public health. However, it would not be permissible to influence, 
directly or indirectly, a specific piece of pending legislation. It 
remains permissible to use CDC funds to engage in activity to enhance 
prevention; collect and analyze data; publish and disseminate results 
of research and surveillance data; implement prevention strategies; 
conduct community outreach services; provide leadership and training, 
and foster safe and healthful environments.
    Recipients of CDC grants and cooperative agreements need to be 
careful to prevent CDC funds from being used to influence or promote 
pending legislation. With respect to conferences, public events, 
publications, and ``grassroots'' activities that relate to specific 
legislation, recipients of CDC funds should give close attention to 
isolating and separating the appropriate use of CDC funds from non-CDC 
funds. CDC also cautions recipients of CDC funds to be careful not to 
give the appearance that CDC funds are being used to carry out 
activities in a manner that is prohibited under Federal law.
AR-14 Accounting System Requirements
    The services of a certified public accountant licensed by the State 
Board of Accountancy or the equivalent must be retained throughout the 
project as a part of the recipient's staff or as a consultant to the 
recipient's accounting personnel. These services may include the 
design, implementation, and maintenance of an accounting system that 
will record receipts and expenditures of Federal funds in accordance 
with accounting principles, Federal regulations, and terms of the 
cooperative agreement or grant.
Capability Assessment
    It may be necessary to conduct an on-site evaluation of some 
applicant organization's financial management capabilities prior to or 
immediately following the award of the grant or cooperative agreement. 
Independent audit statements from a Certified Public Accountant (CPA) 
for the preceding two fiscal years may also be required.
AR-15 Proof of Non-profit Status
    Proof of nonprofit status must be submitted by private nonprofit 
organizations with the application. Any of the following is acceptable 
evidence of nonprofit status: (a) A reference to the applicant 
organization's listing in the Internal Revenue Service's (IRS) most 
recent list of tax-exempt organizations described in section 501(c)(3) 
of the IRS Code; (b) a copy of a currently valid IRS tax exemption 
certificate; (c) a statement from a State taxing body, State Attorney 
General, or other appropriate State Official certifying that the 
applicant organization has a nonprofit status and that none of the net 
earnings accrue to any private shareholders or individuals; (d) a 
certified copy of the organization's certificate of incorporation or 
similar document that clearly establishes nonprofit status; (e) any of 
the above proof for a State or national parent organization and a 
statement signed by the parent organization that the applicant 
organization is a local nonprofit affiliate.
AR-16 Security Clearance Requirement
    All individuals who will be performing work under a grant or 
cooperative agreement in a CDC-owned or leased facility (on-site 
facility) must receive a favorable security clearance, and meet all 
security requirements. This means that all awardee employees, fellows, 
visiting researchers, interns, etc., no matter the duration of their 
stay at CDC must undergo a security clearance process.
AR-22 Research Integrity
    The signature of the institution official on the face page of the 
application submitted under this Program Announcement is certifying 
compliance with the Department of Health and Human Services (DHHS) 
regulations in title 42 part 50, subpart A, entitled ``Responsibility 
of PHS Awardee and Applicant Institutions for Dealing with and 
Reporting Possible Misconduct in Science.''
    The regulation places several requirements on institutions 
receiving or applying for funds under the PHS Act that are monitored by 
the DHHS Office of Research Integrity's (ORI) Assurance Program. For 
examples:
    Section 50.103(a) of the regulation states: ``Each institution that 
applies for or receives assistance under the Act for any project or 
program which involves the conduct of biomedical or behavioral research 
must have an assurance satisfactory to the Secretary (DHHS) that the 
applicant: (1) Has established an

[[Page 33154]]

administrative process, that meets the requirements of this subpart, 
for reviewing, investigating, and reporting allegations of misconduct 
in science in connection with PHS-sponsored biomedical and behavioral 
research conducted at the applicant institution or sponsored by the 
applicant; and (2) Will comply with its own administrative process and 
the requirements of this subpart.''
    Section 50.103(b) of the regulation states that: ``An applicant or 
recipient institution shall make an annual submission to the [ORI] as 
follows: (1) The institution's assurance shall be submitted to the 
[ORI], on a form prescribed by the Secretary, * * * and updated 
annually thereafter * * * (2) An institution shall submit, along with 
its annual assurance, such aggregate information on allegations, 
inquiries, and investigations as the Secretary may prescribe.'' An 
additional policy is added in the year 2000 that ``requires research 
institutions to provide training in the responsible conduct of research 
to all staff engaged in research or research training with PHS funds.
AR-24 Health Insurance Portability and Accountability Act Requirements
    Recipients of this grant award should note that pursuant to the 
Standards for Privacy of Individually Identifiable Health Information 
promulgated under the Health Insurance Portability and Accountability 
Act (HIPAA) (45 CFR parts 160 and 164) covered entities may disclose 
protected health information to public health authorities authorized by 
law to collect or receive such information for the purpose of 
preventing or controlling disease, injury, or disability, including, 
but not limited to, the reporting of disease, injury, vital events such 
as birth or death, and the conduct of public health surveillance, 
public health investigations, and public health interventions. The 
definition of a public health authority includes a person or entity 
acting under a grant of authority from or contract with such public 
agency. CDC considers this project a public health activity consistent 
with the Standards for Privacy of Individually Identifiable Health 
Information and CDC will provide successful recipients a specific grant 
of public health authority for the purposes of this project.
AR-25 Release and Sharing of Data
    The Data Release Plan is the Grantee's assurance that the 
dissemination of any and all data collected under the CDC data sharing 
agreement will be released as follows:
    a. In a timely manner.
    b. Completely, and as accurately as possible.
    c. To facilitate the broader community.
    d. Developed in accordance with CDC policy on Releasing and Sharing 
Data, April 16, 2003, https://www.cdc.gov/od/foia/policies/sharing.htm, 
and in full compliance with the 1996 Health Insurance Portability and 
Accountability Act (HIPPA), (where applicable), The Office of 
Management and Budget Circular A110, (2000) revised 2003, https://
www.whitehouse.gov/omb/query.html?col=omb&qt= Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) 
https://www.4.law.cornell.edu/uscode/5/5/552/html.
    Applications must include a copy of the applicant's Data Release 
Plan. Applicants should provide CDC with appropriate documentation on 
the reliability of the data. Applications submitted without the 
required Plan may be ineligible for award. Award will be made when 
reviewing officials have approved an acceptable Plan. The successful 
applicant and the Program Manager will determine the documentation 
format. CDC recommends data is released in the form closest to micro 
data and one that will preserve confidentiality.

Authority and Regulations

    This program is described in the Catalog of Federal Domestic 
Assistance at https://www.cfda.gov/ and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review. Awards are made under the authorization 
of 399B of the Public Health Service Act (PHS Act), 42 U.S.C. 280e, 
399C of the PHS Act, 42 U.S.C. 280e-1, 399D of the PHS Act, 42 U.S.C. 
280e-2, 317(k)(2) of the PHS Act, 42 U.S.C. 247b(k)(2), and 301(a) of 
the PHS Act, 42 U.S.C. 241(a). All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement. The NIH Grants Policy Statement can be 
found at https://grants.nih.gov/grants/policy/policy.htm.

    Dated: May 31, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention.
[FR Doc. 05-11254 Filed 6-6-05; 8:45 am]
BILLING CODE 4163-18-P